NCT04961684

Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
DEVICE	Solver Pen	One application per day for 3 months
DRUG	Loceryl 5%	One application per week for 3 months

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-09-22
• Completion: 2020-09-22
• First posted: 2021-07-14
• Last updated: 2021-07-14

Locations

1 site across 1 country: Tunisia